Application unlock using a connected physical device and transfer of data therebetween

ABSTRACT

According to one embodiment, a system includes a medical device configured to provide a function to a user, communicate via a wireless communication channel with one or more other devices, and send a signal to shift a medical device application from a locked state to an unlocked state. The system also includes a computing device having wireless communication channels and a processor and logic integrated with and/or executable by the processor. The logic is configured to cause the computing device to communicate with the medical device, execute the medical device application, and shift from the locked state to the unlocked state in response to receiving the signal from the medical device. Core functionality of the medical device application is disabled when the medical device application is in the locked state, and some functionality applicable to the medical device is enabled when the medical device application is in the unlocked state.

FIELD OF THE INVENTION

The present invention relates to software applications, and moreparticularly, this invention relates to unlocking a software applicationusing a connected physical device and transferring data therebetween.

BACKGROUND

Many different types of devices may make use of software applications.The devices may have a variety of different functionalities, including,for example, health and fitness such as activity tracking, monitoring,sensing, as well as serving medical needs or services. In particular,medical devices are available for use by patients and/or healthysubjects, for a variety of different functions, that may make use ofsoftware applications. These medical devices may include, for example,active and/or passive sensing devices, diagnostic devices for conditionand/or disease state, drug administration devices, corrective andconditioning devices, and therapy administration devices, among others.The devices may be specific to a particular function, intended use,patient needs, ailment being treated or diagnosed, methods ofinteraction with the body, or may perform a combination of one or moreof the foregoing. Some intended uses of medical devices comprisemonitoring one or more physiological parameters, providing medicament toa patient (which may be provided orally, through injection, byinhalation, etc.) administering electrical stimulation to certain partsof a patient's body, stimulating certain parts of a patient's body viachanges in physical state (such as temperature, hydration, pressure,etc.), and/or combinations thereof. Some exemplary medical devicesinclude pacemakers, heart monitors, metabolite and/or substance monitors(e.g., glucose monitors), inhalers and nebulizers, substance (drug orpharmaceutical) delivery devices such as drug injection syringes (e.g.,pens), auto-injectors, and imaging and/or scanning devices. Some medicaldevices require a prescription in order to obtain them, and some areavailable “over the counter” without a prescription.

For medical devices which require a prescription, once the medicaldevice is provided to the patient for whom the prescription was suppliedby a heath care provider, it is generally the patient who is responsiblefor ensuring compliance with the prescription and/or proper usage of thedevice. As such there are limited techniques available to ensure thatthe prescription and/or medical device is not misused, either by thepatient or by someone who is not in possession of a prescription to usesuch a medical device.

Furthermore, most medical devices do not include a mechanism thatensures that proper usage of the medical device is always followed, suchas accurately administering medicament only to patients having aprescription, administering the correct medicament and dosage to thepatient for the designated disease or condition, providing medicamentonly as instructed by the prescribing doctor, limiting the amount ofmedicament available over a certain time period, etc. Also, most medicaldevices do not have a mechanism for tracking statistics associated withthe usage of the medical device, such as frequency of use, amount ofmedicament dispersed, time of usage, and dose compliance. Instead, mostcommon medical devices rely on a patient's ability to track andadminister the medicament with only a doctor's instructions on how to doso.

SUMMARY

According to one embodiment, a system includes a medical deviceconfigured to provide a function to a user of the medical device,communicate via a wireless communication channel with one or more otherdevices, and send a signal to shift a medical device application from afirst state to a second state, for example a locked state to an unlockedstate. The system also includes a computing device having one or morewireless communication channels and a processor and logic integratedwith and/or executable by the processor, the logic being configured tocause the computing device to communicate with the medical device,execute the medical device application, and shift from the first orlocked state to the second or unlocked state in response to receivingthe signal from the medical device. Certain functionalities of themedical device application may be disabled when the medical deviceapplication is in the locked state, and at least some functionalityapplicable to the medical device is enabled when the medical deviceapplication is in the unlocked state. For example, a core functionalityof the medical device application may be disabled when in the lockedstate, and some or all functionality of the medical device applicationmay be enabled in the unlocked state.

In another embodiment, a method includes providing, using a medicaldevice, a function to a user of the medical device, communicating via awireless communication channel with one or more other devices, andsending a signal to shift a medical device application executing on acomputing device from a first, e.g., locked state to a second, e.g.unlocked state.

Other aspects and embodiments of the present invention will becomeapparent from the following detailed description, which, when taken inconjunction with the drawings, illustrate by way of example theprinciples of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a network architecture, in accordance with embodiments ofthe present invention.

FIG. 2 shows a representative computing device, according to anembodiment of the present invention.

FIG. 3 shows a medical device and a computing device, according to anembodiment of the present invention.

FIG. 4 shows a medical device application in a locked state, accordingto an embodiment of the present invention.

FIGS. 5A-5B show a medical device application shifting from a lockedstate to an unlocked state, according to an embodiment of the presentinvention.

FIGS. 6A-6B show a medical device application shifting from a lockedstate to an unlocked state, according to an embodiment of the presentinvention.

FIG. 7 shows a flowchart of a method, according to an embodiment of thepresent invention.

FIGS. 8A-8B are perspective views of a passive, capsule-based inhalermedical device, according to an embodiment of the present invention.

DETAILED DESCRIPTION

The following description is made for the purpose of illustrating thegeneral principles of the present invention and is not meant to limitthe inventive concepts claimed herein. Further, particular features,aspects or elements described herein in connection with one embodimentcan be used in combination with other described features, aspects orelements in each of the various possible combinations and permutationsamong the disclosed embodiments.

Unless otherwise specifically defined herein, all terms are to be giventheir broadest possible interpretation including meanings implied fromthe specification as well as meanings understood by those skilled in theart and/or as defined in dictionaries, treatises, etc.

It must also be noted that, as used in the specification and theappended claims, the singular forms “a,” “an,” and “the” include pluralunless otherwise specified.

According to one general embodiment, a system includes a medical deviceconfigured to provide a function to a user of the medical device,communicate via a wireless communication channel with one or more otherdevices, and send a signal to shift a medical device application from afirst or locked state to a second or unlocked state. The system alsoincludes a computing device having one or more wireless communicationchannels and a processor and logic integrated with and/or executable bythe processor, the logic being configured to cause the computing deviceto communicate with the medical device, execute the medical deviceapplication, and shift from the first state to the second state inresponse to receiving the signal from the medical device. In manyembodiments, the first state is a locked state or condition, and thesecond state is an unlocked state or condition. In embodiments of theinvention, a core functionality of the medical device application isdisabled when the medical device application is in the locked state, andat least some functionality applicable to the medical device is enabledwhen the medical device application is in the unlocked state.

In another general embodiment, a method includes providing, using amedical device, a function to a user of the medical device,communicating via a wireless communication channel with one or moreother devices, and sending a signal to shift a medical deviceapplication executing on a computing device from a first or locked stateto second or unlocked state.

The description herein is presented to enable any person skilled in theart to make and use the invention and is provided in the context ofparticular applications of the invention and their requirements. Variousmodifications to the disclosed embodiments will be readily apparent tothose skilled in the art and the general principles defined herein maybe applied to other embodiments and applications without departing fromthe spirit and scope of the present invention Thus, the presentinvention is not intended to be limited to the embodiments shown, but isto be accorded the widest scope consistent with the principles andfeatures disclosed herein.

In particular, various embodiments of the invention discussed herein areimplemented using the Internet as a means of communicating with orbetween a physical device and a computer or a plurality of computersystems. One skilled in the art will recognize that the presentinvention is not limited to the use of the Internet as a communicationmedium and that alternative methods of the invention may accommodate theuse of a private intranet, a Local Area Network (LAN), a Wide AreaNetwork (WAN) or other means of communication. In addition, variouscombinations of wired, wireless (e.g., radio frequency) and opticalcommunication (e.g., visible or infrared) links may be utilized. In someembodiments, communications may be achieved via human audible orinaudible sound. Furthermore, communication may be made between devicesusing quick response (QR) codes, bar codes, radio frequencyidentification (RFID) tags and devices, or video and image capturetechnology.

The program environment in which one embodiment of the invention may beexecuted illustratively incorporates one or more general-purposecomputers or special-purpose devices such hand-held computers. Detailsof such devices (e.g., processor, memory, data storage, input, andoutput devices) are well known and are omitted for the sake of clarity.

It should also be understood that the techniques of the presentinvention might be implemented using a variety of technologies. Forexample, the methods described herein may be implemented in softwarerunning on a computer system, and/or implemented in hardware utilizingone or more processors and logic (hardware and/or software) forperforming operations of the method, application specific integratedcircuits (ASICs), programmable logic devices such as field programmablegate arrays (FPGAs), and/or various combinations thereof. In oneillustrative approach, methods described herein may be implemented by aseries of computer executable instructions residing on a storage medium,such as a physical (e.g., non-transitory) computer readable medium. Inaddition, although specific embodiments of the invention may employobject-oriented software programming concepts, the invention is not solimited and is easily configurable to employ other forms of directingthe operation of a computer.

The invention may also be provided in the form of a computer programproduct comprising a computer readable storage or signal medium havingcomputer code thereon, which may be executed by a computing device(e.g., one or more processors), a system, and/or some other suitabledevice. A computer readable storage medium may include any mediumcapable of storing computer code thereon for use by a computing deviceor system, including optical media such as read only and rewriteable CDand DVD, magnetic memory and/or media (e.g., hard disk drive, tape,etc.), semiconductor memory (e.g., volatile fast access memory,nonvolatile memory, portable memory cards, etc.), or firmware encoded ina microchip.

A computer readable signal medium is one that does not normally fitwithin the aforementioned computer readable storage medium class. Forexample, illustrative computer readable signal media communicate orotherwise transfer transitory signals within a system or betweensystems, e.g., via one or more physical and/or virtual networks. Forexample, a computer readable signal medium may include any communicationsignal that is sent and/or received from one or more devices in anetwork, by one or more of a variety of free space or physical mediadata transfer standards and/or protocols. these may include for exampleEthernet packets sent across an Ethernet connection, wireless datapackets sent across a WIFI network, control signals sent betweeninterconnected devices via copper wiring, optical communications sentover free space or physical links, etc.

FIG. 1 illustrates a network architecture 100, in accordance with oneembodiment. As an option, the present network architecture 100 may beimplemented in conjunction with features from any other embodimentlisted herein, such as those described with reference to the otherfigures. Of course, however, such network architecture 100 and otherspresented herein may be used in various applications and/or inpermutations which may or may not be specifically described in theillustrative embodiments listed herein. Further, the networkarchitecture 100 presented herein may be used in any desiredenvironment.

As shown in FIG. 1, a computing device 102 (which is illustrated as asmart phone but is not so limited) is shown in communication with anetwork 104 and a medical device 106 (which is illustrated as a smartinhaler, but is not so limited).

The network 104 may take any network form including, but not limited toa local area network (LAN), a wide area network (WAN) such as theInternet, a wireless local area network (WLAN) such as WIFI, publicswitched telephone network (PSTN), internal telephone network, etc. Inmore embodiments, the network 104 may include a plurality of networkswhich are interconnected. The networks may be remote from one another,and may span many geographical areas, and possibly around the world.Further, one or more gateways may be coupled between any of the networksand the network 104, and/or may be coupled between the devicesconnecting to the network 104 locally. In use, the one or more gatewaysmay serve as entrance points for data to be sent across the network 104and any networks therein. As such, the one or more gateways may functionas routers, which are capable of directing a given packet of data thatarrives at the gateway, and a switch, which furnishes the actual path inand out of the gateway for a given packet.

The network architecture 100 also shows other exemplary computingdevices connected to the network 104, including a smart watch 108connected to a smart syringe 110, so that the smart watch 108 isconfigured to upload and/or download information relating to thefunctionality of the smart syringe 110 and use thereof from the network104.

In another use case, a heart rate monitor 112 is shown connecteddirectly to the network 104. In this embodiment, the heart rate monitor112 is configured to communicate directly through the network 104 to oneor more devices for uploading and/or downloading information relating tothe functionality and usage of the heart rate monitor 112.

Some other devices connected to the network 104 and possibly accessibleto any of the other devices connected to the network 104 include storage114, a workstation 116, and a server 118. The storage 114 may includeany type of memory known in the art for storing information therein,such as (with reference to FIGS. 1-2) random access memory (RAM) 214,read only memory (ROM) 216, magnetic tape media, hard disk media,optical disk media, non-volatile memory such as flash memory, etc.Furthermore, the storage 114 may be used by any of the other devices forstorage of information and/or data therein, such as by the smart phone102 for storing usage data about the inhaler 106. Also, the storage 114may be used by any of the other devices connected to the network 104 forretrieval of information and/or data therefrom, such as by the smartwatch 108 for retrieving information on a dosage and/or a dosage regimenthe smart syringe 110 is configured to inject. For example this mayrelate to any or all of a dosage amount, range, a maximum, a minimum,and acceptable deviation from a nominal dose.

The workstation 116 may take the form of any type of computing deviceknown in the art, such as a desktop computer, laptop computer, hand-heldcomputer, printer, or any other type of user device or logic.

Further included is at least one server 118 coupled to the network 104,and which is possibly accessible from the other devices connected to thenetwork 104. It should be noted that the server(s) 118 may include anytype of computing device/groupware. Each server 118 may have connectedthereto a plurality of user devices (not shown) and/or storage 120. Suchuser devices may include a desktop computer, laptop computer, hand-heldcomputer, printer, or any other type of user device or logic. It shouldbe noted that a user device may also be directly coupled to the network104, in one embodiment.

According to some approaches, methods and systems described herein maybe implemented with and/or on virtual systems and/or systems whichemulate one or more other systems, such as a UNIX system which emulatesa MAC OS environment, a UNIX system which virtually hosts a MICROSOFTWINDOWS environment, a MICROSOFT WINDOWS system which emulates a MAC OSenvironment, and others known in the art. This virtualization and/oremulation may be enhanced through the use of VMWARE software, in someembodiments.

In more approaches, one or more networks may represent a cluster ofsystems commonly referred to as a “cloud.” In cloud computing, sharedresources, such as processing power, connected storage, peripherals,software, data processing, and/or storage, servers, etc., are providedto any device or system in the cloud, preferably in an on-demandrelationship, thereby allowing access and distribution of servicesacross many computing systems. Cloud computing typically involves anInternet and/or other high speed data connection (e.g., 4G LTE, fiberoptic, etc.) between the systems operating in the cloud, but othertechniques of connecting the systems may also be used, such as WiFi,Bluetooth, etc.

In one embodiment, data may be stored to the cloud by one or moremedical devices which are configured to communicate with a device in thecloud capable of storing such data. This cloud data storage may beutilized whenever the one or more medical devices are capable ofcommunicating with the device in the cloud and have data to be storedtherein. Alternatively or additionally, the one or more medical devicesmay have local data storage capability, and may utilize the cloud asbackup storage and/or overflow storage for data stored locally to theone or more medical devices. In either of these embodiments, when theone or more medical devices communicate with a computing device, thecomputing device is also provided with access to the data stored to thecloud, either directly by accessing the device storing the data in thecloud, or by receiving the data from the one or more medical devices,which access the data stored to the cloud and send it to the computingdevice. One of skill in the art would be able to appreciate andunderstand many other uses of data storage on the cloud, and those usesmay be implemented in the embodiments described herein withoutspecifically reciting all such combinations.

FIG. 2 shows an exemplary computing device 200, in accordance with oneembodiment. The representative computing device 200 may include acentral processing unit 210, such as a microprocessor, and a number ofother units interconnected via a system bus 212.

The computing device 200 shown in FIG. 2 includes RAM 214, ROM 216, anI/O adapter 218 for connecting external devices such as memory 220 tothe bus 212, a user interface adapter 222 for connecting various userinterface devices to the bus 212, such as those internal to thecomputing device 200 (e.g., a touch screen interface 240, a speaker 228,a microphone 232) and devices external to the computing device 200(e.g., a keyboard 224, a mouse 226, etc.), a communication adapter 234for connecting the computing device 200 to a network 242 (e.g., a dataprocessing network, communication network, etc.) and a display adapter236 for connecting the bus 212 to a display screen 238 (which is showninternal to the computing device 200 but may be an external display).

The computing device 200 may have resident thereon an operating system,such as the MICROSOFT WINDOWS Operating System (OS), a MAC OS, a UNIXOS, ANDROID, APPLE iOS, or others known in the art. It will beappreciated that embodiments of the present invention may also beimplemented on platforms and operating systems other than thosementioned. Embodiments of the present invention may be written usingJAVA, XML, C, and/or C++ language, or other programming languages, alongwith an object oriented programming methodology. Object orientedprogramming (OOP), which has become increasingly used to develop complexapplications, may be used.

Now referring to FIG. 3, a medical device 302 is shown along with acomputing device 304, according to one embodiment, In this embodiment,the computing device 304 may comprise any computing device known in theart, such as a personal computer (PC), a mobile telephone (e.g., a smartphone (such as APPLE iPHONE, SAMSUNG GALAXY S3, S4, S5, etc.), cellphone, etc.), a tablet computer (such as an APPLE iPAD, MICROSOFTSURFACE, SAMSUNG GALAXY TAB, AMAZON KINDLE, etc.), a smart watch (e.g.,MOTOROLA MOTO360, ASUS ZENWATCH, APPLE iWATCH, etc.), a laptop computer,an ultrabook computer, or a wearable device (e.g., head-up displaysincluding GOGGLE GLASS and others, tracking and displaying devices likeFITBIT). The computing device 302 is capable of communicating via one ormore wireless communication technologies. Any wireless communicationtechnology capable of receiving a signal and transmitting data to/fromthe medical device 302 may be used, as would be known to one of skill inthe art upon reading the present description.

In embodiments of the present invention, the computing device 304 is asmart phone, as shown, capable of downloading program applications froma central application server. Any central application server may be usedto download program applications, such as APPLE APP STORE, APPLE iTUNES,GOOGLE PLAY STORE, AMAZON APP STORE, etc. Any of these applicationservers may include a medical device application 306 that may bedownloaded onto the computing device 304. Medical device applicationsmay also be downloadable from servers under the control of the providerof the medical device, healthcare providers, pharmacies, hospitals,clinicians, or doctors.

In some embodiments, the medical device 302 may be any medical deviceknown in the art capable of communicating with the computing device 304via a wireless communication technology. Any wireless communicationtechnology may be used for transmitting the signal from the medicaldevice 302 to the medical device application 306, as would be known toone of skill in the art upon reading the present descriptions.

Some exemplary wireless communication technologies include, but are notlimited to, Bluetooth, Bluetooth low energy (BLE), ZIGBEE, Z-WAVE,infrared (IR), WLAN such as WIFI, RF, near-field communication (NFC),and optical.

In another embodiment, a proprietary wireless communication protocol maybe used to send information between the medical device 302 and thecomputing device 304, with the proprietary communication protocol beingconfigured to effectively convey information specific to the medicaldevice 302 and uses thereof.

In some examples, the medical device 302 may comprise a WIFI-enabledglucose meter, an RF-capable heart monitor, a smart syringe capable ofaltering dosages based on one or more criteria and can communicate viaNFC, a Bluetooth-capable implantable insulin injector. Combinations andpermutations of the foregoing devices and communications protocols arecontemplated. In one embodiment, the medical device 302 is an inhalerconfigured to communicate wirelessly. In some embodiments, the wirelessstandard or protocol comprises BLE and/or Bluetooth.

In some further embodiments, the medical device 302 may comprise aprocessor capable of executing logic, a local memory for storing data,and logic which may be accessible to the processor and/or implementedwithin the processor. The logic may be configured to cause the medicaldevice to follow instructions from the computing device, sendinformation from the medical device 302 to the computing device 304, anetworked storage device, other devices within a network, and/or acloud, and receive information from the computing device 304, anetworked storage device, other devices within a network, and/or acloud.

The local memory of the medical device 302 may comprise any memory knownto one of skill in the art, such as RAM, ROM, non-volatile memory (NVM)such as Flash memory, removable memory such as a microSD card.

In accordance with one embodiment, a user of the computing device 304may install a medical device application 306 on the computing device304. The medical device application 306 may be downloaded from anapplication server accessible to the computing device 304, theapplication server being of a type known in the art. In anotherembodiment, the medical device application 306 may be provided to thecomputing device 304, for example via a computer readable storagemedium, such as a CD, MicroSD card, RAM, or ROM, and/or virtuallyprovided via a link and/or pointer that is embedded in a communicationreceived by the computing device 304, such as a hypertext link in anemail, or HTML pointer in a text message. The computing device 304 maythen access the medical device application 306 via the Internet, a WLANsuch as a WIFI network, a WAN, a LAN, etc., to install the medicaldevice application 306 on the computing device 304, as would beunderstood by one of skill in the art upon reading the presentdescriptions.

After the user has caused the medical device application 306 to becomeinstalled on the computing device 304 and started, executed, run, and/oropened the medical device application 306 on the computing device 304,the medical device application 306 will indicate that it is in a firststate, which may be a locked state wherein the medical deviceapplication 306 will not provide functionality, or will not providedesired or complete functionality. Once the medical device application306 has been shifted from the first or locked state to the second orunlocked state, the medical device application 306 will provide thefunctionality, or full or complete or desired functionality, as shown inFIG. 4, in accordance with one embodiment.

In an alternate embodiment, the medical device application 306 may beunlocked upon installation, and will allow the user to access allfunctionality thereof. However, a medical device 302 may not functionunless it has been paired with and/or unlocked by the medical deviceapplication 306.

FIG. 4 is exemplary of an embodiment wherein a screen displays a message402 describing that the medical device application 306 requires that themedical device 302 be paired with the medical device application 306 inorder for the medical device application 306 to provide some or all ofthe medical device application 306 functionality. As shown, link 404provides access to a second screen (not shown) which may provide some orall functionality, for example, the ability to input user informationand medical device 302 information so that once the medical device 302is paired with the medical device application 306, the medical deviceapplication 306 is ready to provide full or complete or desiredfunctionality consistent with and operable by the particular medicaldevice 302.

In another embodiment, pairing the medical device 302 to the medicaldevice application 306 may be accomplished by simply confirming, such asby touching a button on a display screen of the computing device, that amedical device recognized by the medical device application 306 andindicated on a display of the medical device application 306 is themedical device 302 in possession of the user. The indication of themedical device 302 may comprise a unique code, some programmed namerecognizable by the user, a default name of the medical device, a symbolrepresenting the medical device, or some other indication known in theart.

In some embodiments, a medical device 302 is provided which has multipleuse modes, and the medical device application 306 may similarly providemultiple use modes which correspond to the particular use modes of themedical device 302. In this embodiment, the medical device 302 isconfigured to unlock only the functionality of the medical deviceapplication 306 which is appropriate to the desired use mode of themedical device 302. For example, the medical device 302 may be aninhaler which may be suitable to deliver different drugs, and/ordifferent classes of drugs, and/or different dosages. In such anexample, the medical device application 306 which pairs with the medicaldevice 302 in respect of one drug or class of drug or dosage may bedifferent from the medical device application 306 which pairs with themedical device 302 in respect of a different drug or class of drugs ordosage. Hence the pairing and locking mode of the medical deviceapplication 306 helps to supply assurance that the different drugs areused in accordance with their respective directions and posology.

By “pairing,” what is meant in one embodiment is that the medical device302 and the medical device application 306 have connected to oneanother, with the medical device application 306 recognizing the medicaldevice 302, and the medical device 302 providing at least someinformation to the medical device application 306.

In many embodiments, some functions may still be accessible by the userwhile the medical device application 306 is in the locked state, such asaltering settings, inputting personal information, inputting informationabout the medical device 302, etc., in various approaches. However, corefunctionality of the medical device application 306 may only be accessedwhile the medical device application 306 is in the unlocked state. Bythe term “core functionality” is meant the particular functionality thatis necessary or useful to effectuate the purpose of the device. Corefunctionality may differ from device to device and maybe a function ofdevice purpose. Core functionality may include functions that enable amedical device 302 to operate, functions that allow collection of datafrom a medical device 302, and functions that allow the medical deviceapplication to communicate to the medical device 302. For example, ifthe device 302 is a substance (drug or pharmaceutical) delivery devicesuch as an inhaler, the core functionality may comprise theaerosolization and administration to the patient of the appropriatedrug.

Furthermore, in one embodiment, only functionality of the medical deviceapplication 306 that is appropriate for a particular medical device 302may become accessible in the unlocked state, such as to preventconfusion with the operation of the medical device application 306and/or to simplify a user interface of the medical device application306 (such as when operating more than one type of medical device, or amedical device operable with multiple drugs, with the medical deviceapplication 306). By appropriate, what is meant in one embodiment isthat the functionality is consistent with and intended for the medicaldevice 302 and/or the intended patient.

In some embodiments, a user may possess two medical devices 302 such assmart inhalers, each smart inhaler being configured to provide one ormore of a different medicament, dose, formulation, or compound. Forexample, one smart inhaler may provide a drug for treatment of chronicobstructive pulmonary disease (COPD) while the other smart inhaler mayprovide a drug for the treatment of asthma. In such embodiment(s), themedical device application 306 may therefore recognize and understandthe differences between the medical devices (smart inhalers) and mayonly provide functionality on the medical device application 306 for theparticular smart inhaler that is currently paired to the medical deviceapplication 306. In this way, particular operating parameters of thedifferent smart inhalers together with patient posology will beaccounted for and provided in the medical device application 306, forexample dosage amount, frequency of dosage, drug interactions, andadverse effect warnings, when a particular smart inhaler is currentlypaired to the medical device application 306. As a further aspect ofsuch embodiments, the user may possess a single medical device 302 suchas a smart inhaler, however the inhaler may be configured in such a wayas to permit a cartridge or magazine of doses to be functionally coupledto the inhaler. In this case, the medical device application 306 may beable to configure a functional element of the inhaler comprising medicaldevice 302 in one manner for a first drug or class of drugs or dosagecontained in one cartridge, and in a second manner for a second drug orclass of drugs or dosage. Of course this aspect is not limited to onlytwo different drugs or classes of drugs or dosage, but may apply tomultiples thereof.

In another example, a heart rate indicator may be displayed on thecomputing device 304 through the medical device application 306 when themedical device is a heart rate monitor. However, a heart rate indicatorwill not be displayed when the medical device 302 is incapable ofdetecting a user's heart rate, such as when the medical device 302 is asmart syringe, inhaler, glucose monitor, or other non-heart rate enableddevice.

One or more of the following actions may be performed, in variousembodiments, to shift the medical device application 306 from the lockedstate 502 to the unlocked state 504, as shown in FIGS. 5. In variousembodiments, a triggering event may cause the shifting to occur, such aspushing, activating or contacting of one or more buttons 508 on themedical device 302, selection of a graphic (such as a visualrepresentation 506 of a button, medical device) on the medical deviceapplication 306 (possibly after one or more other factors are verified,such as the identity of the user, medical device type, or proximity ofthe medical device 302 to the computing device 304), an attempt toutilize the medical device 302 (such as sensing the inhalation of a userthrough an inhaler, insertion of a needle into an arm of the user for asmart syringe, contact of a sensor pad with skin of a user for a heartrate monitor). Successful pairing is indicated by the wirelesscommunication line 510 (FIG. 5B).

In another embodiment, in order to unlock the medical device application306, more than one triggering event may be required. For example, morethan one medical device 302 may be in the possession of a user, andunlocking the medical device application 306 may be caused by activationof buttons on both medical devices 302 within a predetermined amount oftime, such as 2 seconds, 5 seconds, 10 seconds, 30 seconds, 1 minute,etc. In one example, a first medical device 302 may be an inhaler ornebulizer, while a second medical device 302 may be a medicationcartridge that is insertable into the inhaler or nebulizer. In order tounlock the medical device application 306, a user may depress a buttonon the inhaler or nebulizer (a first trigger), while also bringing themedication cartridge within wireless sensing range of the computingdevice 304 (a second trigger), the proximity of the medication cartridgebeing sensed by the computing device 304.

Once the medical device application 306 is unlocked in this fashion, theidentity of the inhaler or nebulizer and the medication cartridge may beprovided to the medical device application 306, thereby allowing fordosage information to be exchanged between the medical deviceapplication 306 and the inhaler or nebulizer, among other usefulexchange of information between the two medical devices 302 and themedical device application 306 on the computing device 304. In addition,the unlocking of the medical device application 306 may in turn resultin the inhaler or nebulizer being unlocked and the user being able totake a dose of the medication in the cartridge via the inhaler ornebulizer. This results in increased security, and additionalfunctionality not available in conventional medical devices and medicaldevice applications.

As shown in FIGS. 6 in one embodiment, a password may be input into apassword field 602 of the medical device application 306 while themedical device 302 is in communication with the medical deviceapplication 306 in order to shift the medical device application 306from the locked state 502 to the unlocked state 504 (FIG. 6B). Afterthis shift, all appropriate functionality of the medical deviceapplication 306 becomes accessible to the user, provided that the user'smedical device 302 is capable of providing information to the medicaldevice application 306, and is capable of performing actions required bythe medical device application 306 to activate the appropriatefunctionality of the medical device application 306.

In a further embodiment, double security may be provided to theinformation in the medical device application 306 and to the use of themedical device 302 by requiring that not only must a password be enteredin the password field 602 of the medical device application 306, butthat the medical device 302 must be in use and in communication with themedical device application 306 in order to shift the medical deviceapplication 306 from the locked state 502 to the unlocked state 504.

In another embodiment, the medical device 302 may be required to bephysically placed or moved to within communication range of thecomputing device 304 while the medical device application 306 isexecuting on the computing device 304 and is searching for the medicaldevice 302, using a wireless communication technology, referred to asscanning for an available medical device. Once the medical device 302 iswithin communication range of the computing device 304, the medicaldevice application 306 may automatically recognize the presence of themedical device 302, shift to the unlocked state, and allow access to allappropriate functionality for the particular medical device 302 withinrange of the computing device 304. By “all appropriate functionality” ismeant such functionalities as are appropriate to the device, drug (ifapplicable) and user. This may comprise all functionalities of which themedical device application 306 is capable, or it may be a subset thereofas described herein.

In this embodiment, the medical device application 306 may still ensurethat the user, for which at least some personal information has beenentered into the medical device application 306, is intended to be inpossession and/or capable of operating the medical device 302 which hascaused the medical device application 306 to shift to the unlockedstate.

In a further embodiment, should the medical device application 306determine that the medical device 302 is not intended for use by theuser, the medical device application 306 may send an alert to a server(which may be monitored by medical personnel, law enforcement, etc.),shutdown operation of the medical device 302, and/or enter a fault statewhere another security protocol would need to be overcome in order toaccess the medical device application 306 again, such as entering of apassword, requesting from a provider of the medical device 302 a codeand receiving the code to enter into the medical device application 306to verify the user's identity.

According to another embodiment, a token may be wirelessly passed fromthe medical device 302 to the medical device application 306 in order toshift the medical device application 306 from the locked state to theunlocked state. After this shift, all appropriate functionality of themedical device application 306 may become accessible to the user,dependent upon which functionality of the medical device application 306that the user's medical device 302 is capable of utilizing. The tokenmay be specific and unique to at least one of: the user, the medicaldevice 302, a medicament delivered by the medical device 302, theuser/medical device combination, etc., and may be recognizable by themedical device application 306 as being indicative of the aforementionedrelationship. The token may be a string of numbers, letters, characters,an alphanumeric string, or some other identifying electronic signaturecapable of being passed wirelessly from the medical device 302 to themedical device application 306.

In another embodiment, a predefined number of communications between themedical device 302 and the medical device application 306 during apredefined time period may be used in order to shift the medical deviceapplication 306 from the locked state to the unlocked state. After thisshift, all appropriate functionality of the medical device application306 may become accessible to the user, dependent upon whichfunctionality of the medical device application 306 that the user'smedical device 302 is capable of utilizing.

Any number of communications may be used, such as 1, 2, 3, 4, 5, 10, 20or more, in various embodiments. Furthermore, the predefined time periodmay vary based on one or more factors, and may be any amount of time,for example 1 to 100 milliseconds, 1 to 10 seconds, or any valuetherebetween. The factors may include one or more of: a type of themedical device 302, a number of times the medical device application 306has been accessed, a most recent access of the medical deviceapplication 306, the most recent access of the medical device 302, etc.

For example, in some embodiments, three messages sent and receivedwithin one second indicating a unique medical device indicator and aunique medical device application indicator may comprise the decisiontrigger to shift the medical device application 306 from the lockedstate to the unlocked state. An indicator may be a string of numbers,letters, characters, an alphanumeric string, or some other identifyingelectronic signature that is difficult to guess and long enough to beunique for all users in a certain geographic location, such as theworld, a continent, a country, or other natural or politicalsubdivision.

In some embodiments, all appropriate functionality of the medical deviceapplication 306 may be accessible after the medical device application306 has been shifted to the unlocked state once during an initialpairing between the medical device 302 and the medical deviceapplication 306.

In other embodiments, all appropriate functionality of the medicaldevice application 306 may be accessible as long as the medical deviceapplication 306 is maintained in the unlocked state via periodicexchange of messages between the medical device 302 and the medicaldevice application 306 and/or according to random requests for themedical device's unique identifier.

In yet another embodiment, the medical device application 306 may beshifted to the unlocked state each time core functionality is accesseddue to a user attempting to access the medical device 302, but not whennon-core functionality is attempted to be accessed on the medical deviceapplication 306. In this embodiment, the use of non-core functionalityon the medical device application 306 will not affect thelocked/unlocked state of the medical device application 306. However,attempting to use the medical device 302 will result in the medicaldevice application 306 shifting from the locked to the unlocked state.This embodiment is directed at cases where the medical device 302 hasalready been verified to be used by an appropriate user, and thereforeit's pairing with the medical device application 306 is sufficient tounlock the medical device application 306.

In one embodiment, the medical device application 306 may only beoperable with a single medical device 302. Therefore, during a first useof the medical device application 306, information may be provided tothe medical device application 306 about the medical device 302, such asby the user, automatically upon the medical device 302 being broughtwithin wireless communication range of the computing device 304, etc.This information about the medical device 302 may be used to ensure thatno other medical device is allowed to pair to the particular instance ofhe medical device application 306 on the computing device 304.

In another embodiment, the medical device application 306 may beoperable with more than one medical device 302. In this embodiment,during a first use of each of the medical devices 302, information maybe provided to the medical device application 306 about the medicaldevice 302, such as by the user, automatically upon the medical device302 being brought within wireless communication range of the computingdevice 304.

In order for the medical device application 306 to remain in theunlocked state, the computing device 302 may monitor via one or morewireless communication channels for predefined information (transmittedfrom the medical device 302 and received by the computing device 304).The predefined information is captured by the medical device application306 in an initial pairing, and then the predefined information islistened for, such as in a “heartbeat” function (i.e., a system status,periodic signal or synchronization signal) for as long as the medicaldevice application 306 is being accessed by the user.

The heartbeat function may operate by listening for one or morecommunications, the one or more communications being anticipated to bereceived according to a predefined schedule, for example, onecommunication every 10 seconds. When a communication is not received, aproactive message may be sent requesting the communication to ensurethat a device is still in communication with another device.

In some embodiments, the continued use of the medical device application306 triggers a predefined series of communications between the medicaldevice 302 and the medical device application 306 in order to ensurethat the medical device 302 remains in the possession of whomever isaccessing the medical device application 306, to prevent a singlepairing from allowing unfettered access to the medical deviceapplication 306 by someone who is not entitled to such access, toprotect the private medical information of an authorized user fromunauthorized access. The messages that are sent from the medical device302 to the medical device application 306 may be simple, for example,short packets that indicate the identity of the medical device 302 andthe medical device application 306 being accessed. Furthermore, should apredetermined number of messages not be received by the medical deviceapplication 306 as anticipated (as arranged between the medical deviceapplication 306 and the medical device 302 upon the first pairing), themedical device application 306 may terminate the pairing, stop providingsome or all functionality of the medical device application 306 to theuser, and/or restrict access to functionality of the medical device 302.

In further embodiments, in addition to the predefined information, themedical device 302 may send payload data to the computing device 304.This payload data may include any useable information that may begathered, sensed, tracked, created, and/or forwarded by the medicaldevice 302, such as usage data, performance data, patient physiologicdata, energy/battery level and/or battery usage, type of medicament inthe medical device 302, remaining medicament level.

Some exemplary payload data that is transmitted from the medical device302 to the medical device application 306 include total inhalation timefor an inhaler, maximum flow rate during inhalation for an inhaler,minimum flow rate during inhalation for an inhaler, confirmation ofdevice use, confirmation of medicament delivery, total deliveredmedicament, medicament delivery profile or rate, heart rate (for a heartrate monitor), one or more times of activation of the medical device302, length of medical device 302 activation, among others.

The medical device application 306, upon receiving the signal from themedical device 302, may process the signal to obtain the payload data,and may then define parameters for operation of the medical deviceapplication 306. The parameters may include an image to display thatmatches the medical device 302, a name of the medical device to display,a type of medicament being utilized by the user and stored in themedical device 302, how to interact with the user based on the type ofmedical device and/or medicament being used, etc. In addition, themedical device application 306, in response to receiving the signal, maycompute operating information to display to the user that is relevant tothe medical device 302. Operating information may include any usefulinformation to allow the user to utilize the medical device 302.Operating information may also comprise information which relates topatient safety, drug interactions, patient device usage data, andpatient physiologic data.

In various approaches, the operating information may include one or moreof the following: a number of doses of medicament to take in a certainperiod of time (e.g., two doses per day), times for use of the medicaldevice 302 (e.g., check heart rate at 6:00 AM, 12:00 PM, and 6:00 PM),medicament name and drug interaction information (e.g., do not takeacetaminophen with alcohol), etc.

In one embodiment, the medical device application 306 may utilize astrength of the signal received from the medical device 302 to determinea proximity of the medical device to the computing device 304. This maybe useful for operation within a medical care facility, such as ahospital, nursing home, etc., to enable the computing device 304 todetermine which of a plurality of signals is the “right” signal toprocess, e.g., the closest signal. However, the computing device 304 maycycle through the plurality of signals until the signal that providesthe appropriate predefined information is located, and then may lockonto that signal to the exclusion of all others.

The medical device 302 remembers and stores computing devices to whichit has been paired previously in an internal memory of the medicaldevice, in one embodiment. The medical device, upon being unpaired, willpair to these computing devices preferentially to any other computingdevice(s).

Now referring to FIG. 7, a flowchart of a method 700 is shown accordingto one embodiment. The method 700 may be performed in accordance withthe present invention in any of the environments depicted in FIGS. 1-6,among others, in various embodiments. Of course, more or feweroperations than those specifically described in FIG. 7 may be includedin method 700, as would be understood by one of skill in the art uponreading the present descriptions.

Each of the steps of the method 700 may be performed by any suitablecomponent of the operating environment. For example, in variousembodiments, the method 700 may be partially or entirely performed by acomputing device, a medical device capable of communicating via one ormore wireless technologies, or some other device having one or moreprocessors therein. The processor, e.g., processing circuit(s), chip(s),and/or module(s) implemented in hardware and/or software, and preferablyhaving at least one hardware component may be utilized in any device toperform one or more steps of the method 700. Illustrative processorsinclude, but are not limited to, a central processing unit (CPU), anASIC, a FPGA, CPLD, SoCs, etc., combinations thereof, or any othersuitable computing device known in the art.

As shown in FIG. 7, method 700 may initiate with operation 702, where afunction is provided by a medical device to a user of the medicaldevice. Any known function, as appropriate to the medical device andintended use, may be provided. In some embodiments, the function maycomprise one or more of: providing an aerosolized medicament for userinhalation, providing a liquid medicament for user injection, sensing aphysiological condition of the user, sensing and ambient condition orany combination thereof.

In some exemplary embodiments, the function may comprise delivery ofmedicament to the lungs of the user (when the medical device is aninhaler), injection of a liquid drug into the body of the user (when themedical device is a smart syringe or insulin pump), detection of acardiac parameter of the user (when the medical device is a cardiacsensor), delivery of a dosage form (where the medical device is a pilldispenser), and the like.

In operation 704, one or more other devices are communicated with,wirelessly via a wireless communication channel, by the medical device,such as a computing device, other medical devices, and others asdescribed herein and/or known or developed in the art.

In operation 706, a signal is sent from the medical device to acomputing device to shift a medical device application executing on thecomputing device from a locked state to an unlocked state. This signalmay take any known form as described herein, such as one or more packetstransmitted via Bluetooth, a series of transmissions made via RF, etc.

According to some optional operations, the computing device maycommunicate with the medical device, preferably via one or more wirelesscommunication channels. Furthermore, the computing device may executethe medical device application using a processor of the computing deviceand local memory of the computing device. Also, the medical deviceapplication may be shifted from the locked state to the unlocked statein response to receiving the signal from the medical device. While themedical device application is in the locked state core functionality ofthe medical device application is disabled. Then, while the medicaldevice application is in the unlocked state, at least some functionality(including at least some of the core functionality) of the medicaldevice application that is applicable to the medical device is enabled.

According to some embodiments, the medical device may be a smartunit-dose inhaler of a type described herein, or any other known in theart, such as a multi-dose inhaler, passive inhaler, active inhaler,nebulizer, auto-injector or other dose delivery device.

In one embodiment, method 700 may further include disablingfunctionality of the medical device when the medical device is not incommunication with the medical device application on the computingdevice. This operation may result in restricting access of the medicaldevice from those who are not in possession of the medical deviceapplication and/or are not permitted to use the medical device.

In another embodiment, method 700 may further include attempting toconnect with the medical device, using the computing device, in responseto the user providing a trigger. The trigger may be any event, action,condition, response known in the art that is capable of being recognizedby the medical device application executing on the computing device.Further, method 700 may include pairing the medical device with themedical device application on the computing device, in response toreceiving this signal. Method 700 may also include sending one or moremessages from the computing device to the medical device indicatingparameters for operation of he medical device after pairing issuccessful.

In yet another embodiment, method 700 may further include sending amessage from the medical device to the medical device application on thecomputing device in response to a triggering event. Here, the triggeringevent may be any action, event, condition, response known in the artthat is capable of being recognized by the medical device. Further,method 700 may include pairing the medical device with the medicaldevice application on the computing device in response to recognition ofthe trigger. Thereafter, method 700 may include sending one or moremessages from the medical device to the medical device applicationindicating status and/or parameters for operation of the medical device.

In some exemplary embodiments, the triggering event may be selected froma group consisting of: the user pushing, activating or contacting abutton on the medical device, the medical device being brought within awireless communication range of the computing device, and an attempt toutilize the medical device.

In many embodiments, only functionality of the medical deviceapplication that is appropriate for a particular medical device isenabled while the medical device application is in the unlocked state,appropriate functionality being consistent with and possible when usingthe medical device. Therefore, functionality that is inconsistent with,impossible to use, and/or inapplicable to a certain medical device willnot be enabled on the medical device application to avoid confusion,inappropriate use or misuse.

According to yet another embodiment, method 700 may further includesending a predefined series of messages from the medical device to themedical device application on the computing device after sending thesignal to shift the medical device application from the locked state tothe unlocked state. Method 700 may then include listening (i. e. waitingfor a signal), using the medical device application on the computingdevice, for the predefined series of messages from the medical device.Further, method 700 may include disabling core functionality of themedical device application in response to a determination that apredetermined number of messages have not been received by the medicaldevice application as anticipated.

In some embodiments, the medical device comprises a passive (patientinspiratory-actuated) inhaler for the delivery of medicament to thelungs of the user. One example of such an inhaler is a passive,capsule-based inhaler as described more fully in U.S. Pat. No. 8,479,730and in U.S. Patent Publication No. 2014/0000603, the disclosures ofwhich are fully incorporated by reference herein for all purposes.

Referring to FIGS. 8A-8B, an exemplary inhaler 800 for powderedmedicaments comprises, generally, a body 802 that has a recess 804 forholding a capsule (not shown) containing a powdered medicament to beinhaled, at least one air inlet 806, and a mouthpiece 808 that includesa coaxially disposed inhalation passage 810 that communicates with therecess 804 of the body 802. The body 802 has a pair of opposed biasedpush-buttons 812 that each include at least one piercing element (notshown) for piercing the capsule when loaded in the recess 804. Themedicament is released from the pierced capsule when air is drawnthrough the air inlets(s) 806 into the recess 804 and swirled abouttherein. The mouthpiece 808 is pivotally attached to the edge of thebody 802 so that it is pivotable between an open loading position and aclosed dispensing position about an axis that is perpendicular to alongitudinal axis of the inhaler 800. It should be noted that theexemplary inhaler 800 is a more specific embodiment of the medicaldevice 302 shown in FIGS. 3-6.

With continued reference to FIGS. 8A-8B, in use, the user moves themouthpiece 808 from its closed position (FIG. 8A) to its open position(FIG. 8B) and places a capsule (not shown) containing a powderedmedicament to be administered in the recess 804. The user then moves themouthpiece back to its closed position ready for dispensing themedicament. The user presses both push-buttons 812 substantiallysimultaneously to activate a capsule piercing mechanism.

Once the capsule has been pierced the medicament contained therein isavailable to be administered by pulmonary inhalation. The user releasesthe push-buttons 812 and the user then grips the body 802 of the deviceonce again. The medicament is administered by the user breathing outfully, inserting the mouthpiece 808 into the mouth, sealing theinterface by placing their lips and teeth around the mouthpiece andinhaling quickly and deeply.

In some embodiments, the present invention provides an inhalercomprising a capsule housing for containing a medicament capsule, anairflow path through which air flows during an airflow event from atleast one air inlet to an outlet, the airflow path passing through thecapsule housing, a first sensor, a processor and a power source forpowering the processor, the capsule housing being defined by at leastone wall and configured such that when a capsule is located in thecapsule housing and sufficient air flows along the airflow path throughthe capsule housing, the capsule moves within the capsule housing, thefirst sensor is arranged on the inhaler so that it is able to detect themovement of the capsule within the capsule housing and generate a firstsignal indicative of said movement, the processor receiving the firstsignal from the sensor and using said first signal to determine whetherthe first signal is indicative of the presence, or absence, of a capsulein the capsule housing during an airflow event and generate a capsulesignal indicative thereof.

The inhaler is intended to enable the delivery of medicament from thecapsule to an airway, for example the lung, of a user. The medicamentmay be a dry powder, a liquid, or some other suitable formulation andmay include one or more active components for treating one or moredisease states or conditions. The medicament may include one or morenon-active components which may be for stabilising, bulking, and/orotherwise changing one or more characteristics of the formulation. Themedicament may also be free of any active component, for example themedicament may be a placebo.

The capsule for use in the inhaler device may include a powderedmedicament that is suitable for inhalation, in one embodiment. Themedicament may preferably be suitable for the treatment of asthma and/orCOPD, for example one or more bronchodilators, anti-muscarinics,anti-inflammatories, or combinations thereof. Preferred bronchodilatorsinclude beta-2 adrenoceptor agonists such as indacaterol, albuterol(salbutamol), salmeterol, formoterol, and pharmaceutically acceptablesalts thereof.

Suitable antimuscarinic agents include ipratropium bromide, oxitropiumbromide, tiotropium, glycopyrrolate, and pharmaceutically acceptablesalts thereof, Suitable anti-inflammatory drugs include steroids, inparticular glucocorticosteroids such as budesonide, beclomethasonedipropionate, fluticasone propionate, ciclesonide or mometasone furoate,or steroids. Other suitable actives, salts, and compounds are describedin WO 00/75114, WO 04/16601, and WO 02/00679, each of which isincorporated fully herein by reference.

The sensor may be any suitable type of sensor able to generate a signalcapable of being processed to provide a determination of whether acapsule is present in the inhaler. For example an optical sensor couldbe arranged to monitor the capsule housing and a signal from said sensorcould be processed to determine if the signal is indicative of capsulemovement in the capsule housing.

In some embodiments the inhaler includes a first sensor which is animpact sensor and the first signal is an impact signal. The sensor isarranged on the inhaler so that it is able to detect the movement of thecapsule within the capsule housing. The sensor may detect the movementdirectly, for example an optical sensor viewing the capsule movement. Inan alternate embodiment, the sensor may detect movement indirectly bysensing a parameter that may be analysed to determine the presence orabsence of a characteristic linked with movement of the capsule, forexample the impact of the capsule with a wall, or a variation in the airflow pattern as the capsule moves across air inlets or outlets.

In some more embodiments of the invention, and referring to exemplaryinhaler 800 of FIGS. 8A-8B, one or both push buttons 812 (which are morespecific functional embodiments of the button(s) 508 of FIG. 5) may beemployed to actuate the unlock signal which is sent to the computingdevice to unlock the medical device application. Upon receiving theunlock signal from the inhaler, core functionality of the medical deviceapplication may be unlocked and accessible by the user.

While various embodiments have been described above, it should beunderstood that they have been presented by way of example only, and notlimitation. Thus, the breadth and scope of a preferred embodiment shouldnot be limited by any of the above-described exemplary embodiments, butshould be defined only in accordance with the following claims and theirequivalents.

What is claimed is:
 1. A system, comprising: a medical device configuredto: provide a function to a user of the medical device; communicate viaa wireless communication channel with one or more other devices; andsend a signal to shift a medical device application from a locked stateto an unlocked state; and a computing device comprising one or morewireless communication channels and a processor and logic integratedwith and/or executable by the processor, the logic being configured tocause the computing device to: communicate with the medical device;execute the medical device application; and shift from the locked stateto the unlocked state in response to receiving the signal from themedical device, wherein a functionality of the medical deviceapplication is disabled when the medical device application is in thelocked state, and wherein a functionality applicable to the medicaldevice is enabled when the medical device application is in the unlockedstate.
 2. The system as recited in claim 1, wherein the medical deviceis a unit-dose inhaler.
 3. The system as recited in claim 1, wherein afunctionality of the medical device is disabled when it is not incommunication with the medical device application on the computingdevice.
 4. The system as recited in claim 1, wherein the functioncomprises one or more of: providing an aerosolized medicament for userinhalation, providing a liquid medicament for user injection, andsensing a physiological condition of the user.
 5. The system as recitedin claim 1, wherein the computing device is selected from a groupconsisting of: a personal computer, a smart phone, a smart watch, awearable device, a tablet computer, and a laptop computer.
 6. The systemas recited in claim 1, wherein the wireless communication channel of themedical device is configured to communicate with the wirelesscommunication channel of the computing device via one or more radiofrequencies.
 7. The system as recited in claim 1, wherein the computingdevice is further configured to: attempt to connect with the medicaldevice in response to the user providing a trigger; pair with themedical device with the medical device application; and send one or moremessages to the medical device indicating parameters for operation ofthe medical device.
 8. The system as recited in claim 1, wherein themedical device is further configured to: send a message to the medicaldevice application on the computing device in response to a triggeringevent; pair with the medical device application on the computing device;and send one or more messages to the medical device applicationindicating status and/or parameters for operation of the medical device.9. The system as recited in claim 8, wherein the triggering event isselected from a group consisting of: the user depressing a button on themedical device, the medical device being brought within a wirelesscommunication range of the computing device, and an attempt to utilizethe medical device.
 10. The system as recited in claim 1, wherein onlyfunctionality of the medical device application that is appropriate fora particular medical device is enabled while the medical deviceapplication is in the unlocked state, appropriate functionality beingconsistent with and possible when using the medical device.
 11. Thesystem as recited in claim 1, wherein the medical device is furtherconfigured to send a predefined series of messages to the medical deviceapplication on the computing device after sending the signal to shiftthe medical device application from the locked state to the unlockedstate, and wherein the medical device application is further configuredto: listen for the predefined series of messages from the medicaldevice; and disable a core functionality of the medical deviceapplication in response to a determination that a predetermined numberof messages have not been received by the medical device application asanticipated.
 12. A method, comprising: providing, using a medicaldevice, a function to a user of the medical device; communicating via awireless communication channel with one or more other devices; andsending a signal to shift a medical device application executing on acomputing device from a first state to a second state.
 13. The method asrecited in claim 12, further comprising: communicating, using thecomputing device, with the medical device; executing, using thecomputing device, the medical device application; and shifting themedical device application from the first state to the second state inresponse to receiving the signal from the medical device, wherein afunctionality of the medical device application is disabled when themedical device application is in the second state, and wherein afunctionality applicable to the medical device is enabled when themedical device application is in the second state.
 14. The method asrecited in claim 12, wherein the medical device is a unit-dose inhaler.15. The method as recited in claim 12, further comprising disablingfunctionality of the medical device when the medical device is not incommunication with the medical device application on the computingdevice.
 16. The method as recited in claim 12, wherein the functioncomprises one or more of: providing an aerosolized medicament for userinhalation, providing a liquid medicament for user injection, andsensing a physiological condition of the user.
 17. The method as recitedin claim 12, further comprising: attempting to connect with the medicaldevice, using the computing device, in response to the user providing atrigger; pairing the medical device with the medical device applicationon the computing device; and sending one or more messages from thecomputing device to the medical device indicating parameters foroperation of the medical device.
 18. The method as recited in claim 12,further comprising: sending a message from the medical device to themedical device application on the computing device in response to atriggering event; pairing the medical device with the medical deviceapplication on the computing device; and sending one or more messagesfrom the medical device to the medical device application indicatingstatus and/or parameters for operation of the medical device, whereinthe triggering event is selected from a group consisting of: the userdepressing a button on the medical device, the medical device beingbrought within a wireless communication range of the computing device,and an attempt to utilize the medical device.
 19. The method as recitedin claim 12, wherein only functionality of the medical deviceapplication that is appropriate for a particular medical device isenabled while the medical device application is in the unlocked state,appropriate functionality being consistent with and possible when usingthe medical device.
 20. The method as recited in claim 12, furthercomprising: sending a predefined series of messages from the medicaldevice to the medical device application on the computing device aftersending the signal to shift the medical device application from thefirst state to the second state; listening, using the medical deviceapplication on the computing device, for the predefined series ofmessages from the medical device; and disabling a core functionality ofthe medical device application in response to a determination that apredetermined number of messages have not been received by the medicaldevice application.